Irritability Memory decreased Paresthesia Central nervous System stimulation |
3% - 1% 2% |
2% 3% 2% 1% |
2% 1% 1% 1% |
Respiratory Pharyngitis Sinusitis Increased cough |
3% 3% 1% |
11% 1% 2% |
2% 2% 1% |
Skin Sweating Rash Pruritus Urticaria |
6% 5% 2% 2% |
5% 4% 4% 1% |
2% 1% 2% 0% |
Special senses Tinnitus Taste perversion Amblyopia |
6% 2% 3% |
6% 4% 2% |
2% - 2% |
Urogenital Urinary frequency Urinary urgency Vaginal hemorrhage† Urinary tract infection |
2% - 0% 1% |
5% 2% 2% 0% |
2% 0% - - |
530
*Adverse
events that occurred in at least 1% of patients treated with either 300 or
531
400
mg/day of the sustained-release formulation of bupropion, but equally or more
532
frequently
in the placebo group, were: abnormal dreams, accidental injury, acne, appetite
533
increased,
back pain, bronchitis, dysmenorrhea, dyspepsia, flatulence, flu syndrome,
534
hypertension,
neck pain, respiratory disorder, rhinitis, and tooth disorder.
535
†Incidence based on the number of female
patients.
536
–
Hyphen denotes adverse events occurring in greater than 0 but less than 0.5% of
patients.
537
538
Additional events to those listed in
Table 4 that occurred at an incidence of at least 1% in
539
controlled
clinical trials of the immediate-release formulation of bupropion (300 to 600
mg/day)
540
and
that were numerically more frequent than placebo were: cardiac arrhythmias (5%
vs 4%),
541
hypertension
(4% vs 2%), hypotension (3% vs 2%), tachycardia (11% vs 9%), appetite increase
542
(4%
vs 2%), dyspepsia (3% vs 2%), menstrual complaints (5% vs %), akathisia (2% vs
1%),
543
impaired
sleep quality (4% vs 2%), sensory disturbance (4% vs 3%), confusion (8% vs 5%)
17
Back a Page
Next Page
Back to Wellbutrin XL NDA Index Page
Back to Main Index Page